FATE-NK100 is a first-in-class natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of natural killer cells. We are executing on a multi-pronged clinical development strategy for FATE-NK100 addressing both hematologic and solid tumor malignancies, including as a monotherapy and in combination with other anti-tumor agents such as monoclonal antibodies.
In preclinical studies, FATE-NK100 has demonstrated enhanced anti-tumor activity across a broad range of liquid and solid tumors, improved persistence, and increased resistance to immune checkpoint pathways compared to NK cell therapies that are being clinically administered today. Additionally, FATE-NK100 has been shown in preclinical models to significantly augment antibody-directed cellular cytotoxicity against cancer cells when administered in combination with a monoclonal antibody, including antibodies that target CD20, HER2 and EGFR antigens.
FATE-NK100 is produced through a feeder-free, seven-day manufacturing process during which natural killer cells sourced from a healthy donor are activated ex vivo with pharmacologic modulators, inducing the robust formation of adaptive memory NK cells.
A clinical trial of FATE-NK100 has been initiated at the Masonic Cancer Center, University of Minnesota for the treatment of refractory or relapsed AML. The VOYAGE study is utilizing accelerated dose-escalation to evaluate the safety and determine the maximum dose of a single intravenous infusion of FATE-NK100. The anti-tumor activity of FATE-NK100, including rates of complete response, clearance of minimal residual disease, disease-free survival and overall survival, is also being assessed.
There is growing preclinical and clinical evidence demonstrating that the efficacy of monoclonal antibody therapy, both in hematologic and solid tumor malignancies, is NK cell-mediated. The U.S. Food and Drug Administration has cleared our investigational new drug application for the clinical investigation of FATE-NK100 in subjects with advanced solid tumor malignancies, including in combination with monoclonal antibody therapy. We plan to enroll subjects concurrently across three FATE-NK100 treatment arms: as monotherapy for solid tumor malignancies, including small cell lung cancer and hepatocellular carcinoma; in combination with trastuzumab for advanced HER2+ cancers, including breast and gastric cancers; and in combination with cetuximab for advanced EGFR1+ cancers, including colorectal and head and neck cancers. Accelerated dose-escalation will be utilized to evaluate the safety and anti-tumor activity of FATE-NK100 in an outpatient setting.
We are planning to investigate the safety and activity of escalating doses of FATE-NK100 administered intra-peritoneally in women with advanced ovarian, fallopian tube or primary peritoneal cancer. This setting provides a unique opportunity to evaluate the persistence and anti-tumor activity of FATE-NK100 when delivered directly to the site of tumor via IP administration. The APOLLO study is expected to enroll platinum-resistant subjects as well as platinum-sensitive subjects following tumor progression.